Recalls / Class III
Class IIID-1212-2018
Product
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 69097-875, 69097-876
- FDA application
- ANDA206556
- Affected lot / code info
- Lot #: a) 1612130, 1612131, Exp 11/18; 1709986, Exp 8/19; 1711549, Exp 10/19; b) 1701171, 1701174, 1701175, 1701176, Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19; 17110257, Exp 9/19; 1712809, 1801041, 1801051, Exp 12/19; 1802283, Exp 1/20
Why it was recalled
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Manufacturer
- CIPLA USA INC.,
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Oser Ave, N/A, Hauppauge, New York 11788-3811
Distribution
- Quantity
- 26,496 bottles
- Distribution pattern
- Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
Timeline
- Recall initiated
- 2018-09-06
- FDA classified
- 2018-09-25
- Posted by FDA
- 2018-09-26
- Terminated
- 2020-10-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1212-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.